Implementing Enhanced Recovery After Surgery for hysterectomy in a hospital network with audit and feedback: A stepped-wedge cluster randomised trial.

OBJECTIVE: To evaluate the effectiveness of implementing the Enhanced Recovery After Surgery (ERAS) protocol in patients undergoing elective hysterectomy in a network of regional hospitals, supported by an intensive audit-and-feedback (A&F) approach. DESIGN: A multi-centre, stepped-wedge cluster randomised trial (ClinicalTrials.gov NCT04063072). SETTING: Gynaecological units in the Piemonte region, Italy. POPULATION: Patients undergoing elective hysterectomy, either for cancer or for benign conditions. METHODS: Twenty-three units (clusters), stratified by surgical volume, were randomised into four sequences. At baseline (first 3 months), standard care was continued in all units. Subsequently, the four sequences implemented the ERAS protocol successively every 3 months, after specific training. By the end of the study, each unit had a period in which standard care was maintained (control) and a period in which the protocol, supported by feedback, was applied (experimental). MAIN OUTCOME MEASURES: Length of hospital stay (LOS), without outliers (>98th percentile). RESULTS: Between September 2019 and May 2021, 2086 patients were included in the main analysis with an intention-to-treat approach: 1104 (53%) in the control period and 982 (47%) in the ERAS period. Compliance with the ERAS protocol increased from 60% in the control period to 76% in the experimental period, with an adjusted absolute difference of +13.3% (95% CI 11.6% to 15.0%). LOS, moving from 3.5 to 3.2 days, did not show a significant reduction (-0.12 days; 95% CI -0.30 to 0.07 days). No difference was observed in the occurrence of complications. CONCLUSIONS: Implementation of the ERAS protocol for hysterectomy at the regional level, supported by an A&F approach, resulted in a substantial improvement in compliance, but without meaningful effects on LOS and complications. This study confirms the effectiveness of A&F in promoting important innovations in an entire hospital network and suggests the need of a higher compliance with the ERAS protocol to obtain valuable improvements in clinical outcomes.

Impact of different follow-up regimens on health-related quality of life and costs in endometrial cancer patients: Results from the TOTEM randomized trial.

PURPOSE: To investigate whether intensive follow-up (INT) after surgery for endometrial cancer impact health-related quality of life (HRQoL) and healthcare costs compared to minimalist follow-up (MIN), in the absence of evidence supporting any benefit on 5-year overall survival. METHODS: In the TOTEM trial, HRQoL was assessed using the SF-12 and the Psychological General Well-Being (PGWB) questionnaires at baseline, after 6 and 12 months and then annually up to 5 years of follow-up. Costs were analyzed after 4 years of follow-up from a National Health Service perspective, stratified by risk level. The probability of missing data was analyzed for both endpoints. RESULTS: 1847 patients were included in the analyses. The probability of missing data was not influenced by the study arms (MIN vs INT OR: 0.97 95%CI: 0.87-1.08). Longitudinal changes in HRQoL scores did not differ between the two follow-up regimens (MIN vs INT SF-12 PCS: -0.573, CI95%: -1.31; 0.16; SF-12 MCS: -0.243, CI95%: -1.08; 0.59; PGWB: -0.057, CI95%: -0,88; 0,77). The mean cost difference between the intensive and minimalist arm was €531 for low-risk patients and €683 for high-risk patients. CONCLUSION: In the follow-up of endometrial cancer after surgery, a minimalist treatment regimen did not affect quality of life and was cost-saving in both low-risk and high-risk recurrence patients. As previous results showed no survival benefit, a minimalist approach is justified. The relevant proportion of missing data on secondary outcomes of interest could be a critical point that deserves special attention.

Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention. METHODS: A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items. RESULTS: Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68). CONCLUSION: Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. Trial registration number NCT04037787.

Genomic instability analysis in DNA from Papanicolaou test provides proof-of-principle early diagnosis of high-grade serous ovarian cancer.

Late diagnosis and the lack of screening methods for early detection define high-grade serous ovarian cancer (HGSOC) as the gynecological malignancy with the highest mortality rate. In the work presented here, we investigated a retrospective and multicentric cohort of 250 archival Papanicolaou (Pap) test smears collected during routine gynecological screening. Samples were taken at different time points (from 1 month to 13.5 years before diagnosis) from 113 presymptomatic women who were subsequently diagnosed with HGSOC (pre-HGSOC) and from 77 healthy women. Genome instability was detected through low-pass whole-genome sequencing of DNA derived from Pap test samples in terms of copy number profile abnormality (CPA). CPA values of DNA extracted from Pap test samples from pre-HGSOC women were substantially higher than those in samples from healthy women. Consistently with the longitudinal analysis of clonal pathogenic TP53 mutations, this assay could detect HGSOC presence up to 9 years before diagnosis. This finding confirms the continual shedding of tumor cells from fimbriae toward the endocervical canal, suggesting a new path for the early diagnosis of HGSOC. We integrated the CPA score into the EVA (early ovarian cancer) test, the sensitivity of which was 75% (95% CI, 64.97 to 85.79), the specificity 96% (95% CI, 88.35 to 100.00), and the accuracy 81%. This proof-of-principle study indicates that the early diagnosis of HGSOC is feasible through the analysis of genomic alterations in DNA from endocervical smears.

Prediction of Early and Long-Term Hospital Readmission in Patients with Severe Obesity: A Retrospective Cohort Study.

Adults with obesity have a higher risk of hospitalization and high hospitalization-related healthcare costs. However, a predictive model for the risk of readmission in patients with severe obesity is lacking. We conducted a retrospective cohort study enrolling all patients admitted for severe obesity (BMI ≥ 40 kg/m2) between 2009 and 2018 to the Istituto Auxologico Italiano in Piancavallo. For each patient, all subsequent hospitalizations were identified from the regional database by a deterministic record-linkage procedure. A total of 1136 patients were enrolled and followed up for a median of 5.7 years (IQR: 3.1-8.2). The predictive factors associated with hospital readmission were age (HR = 1.02, 95%CI: 1.01-1.03, p < 0.001), BMI (HR = 1.02, 95%CI: 1.01-1.03, p = 0.001), smoking habit (HR = 1.17, 95%CI: 0.99-1.38, p = 0.060), serum creatinine (HR = 1.22, 95%CI: 1.04-1.44, p = 0.016), diabetes (HR = 1.17, 95%CI: 1.00-1.36, p = 0.045), and number of admissions in the previous two years (HR = 1.15, 95%CI: 1.07-1.23, p < 0.001). BMI lost its predictive role when restricting the analysis to readmissions within 90 days. BMI and diabetes lost their predictive roles when further restricting the analysis to readmissions within 30 days. In conclusion, in this study, we identified predictive variables associated with early and long-term hospital readmission in patients with severe obesity. Whether addressing modifiable risk factors could improve the outcome remains to be established.

Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial.

PURPOSE: In the absence of clear evidence from randomized trials, the intensity of follow-up regimens after surgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, we conducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimen improves overall survival (OS) in patients undergoing operation for endometrial cancer. METHODS: The TOTEM study was a large, pragmatic randomized trial, conducted in 42 hospitals (in Italy and France) including patients surgically treated for endometrial cancer, in complete clinical remission, International Federation of Gynecology and Obstetrics stage I-IV. After stratification by center and risk of relapse (low or high), patients were randomly assigned (1:1) to INT or MIN hospital-based follow-up regimens. The study was powered to demonstrate an absolute improvement of 5% of the 5-year OS with the INT regimen. RESULTS: In total, 1,871 patients were randomly assigned between November 2008 and July 2018, and 1,847 patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the 5-year OS was 90.6% in the INT and 91.9% in the MIN arms (hazard ratio, 1.13, 95% CI, 0.86 to 1.50, P = .380). No differences in OS were found in subgroup analyses considering age, cancer treatment, risk of relapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapse was slightly higher in the INT arm (hazard ratio, 1.17; 95% CI, 0.92 to 1.48; P = .194). CONCLUSION: An INT follow-up in endometrial cancer-treated patients does not improve OS, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the MIN regimens used in this trial.

Ten-year outcomes after off-pump and on-pump coronary artery bypass grafting: an inverse probability of treatment weighting comparative study.

AIMS: The debate on the advantages and limitations of off-pump myocardial revascularization (OPCAB) on long-term outcomes has not still arrived to a conclusion. This study was designed to compare the impact of OPCAB vs, on-pump coronary artery bypass grafting (CABG) on long-term mortality and major adverse cardiac and cerebrovascular events (MACCEs). METHODS: The PRIORITY project was designed to evaluate the long-term outcomes of two large prospective multicenter cohort studies on CABG. Data on isolated CABG were linked to two administrative datasets. The inverse probability of treatment weight was employed to balance the treatment groups. Time-to-event methods were employed to analyze endpoints. RESULTS: The cohort consisted of 10 988 patients who underwent isolated CABG (27.2% OPCAB). The median follow-up time was 7.9 years and was 100% complete. Unadjusted long-term survival was significantly worst for OPCAB, confirmed by weighted models (hazard ratio 1.08, 95% confidence interval (CI) 1.01-1.14, P = 0.01). OPCAB was associated to an increased risk of MACCE at 10 years (weighted hazard ratio 1.18, 95% CI 1.12-1.23, P < 0.001). Inside the MACCEs, OPCAB was significantly related to increased incidence of repeat revascularization (hazard ratio 2.27, 95% CI 1.39-3.85, P < 0.001, in the first 6 months, hazard ratio 1.19, 95% CI 1.09-1.32, P < 0.001 afterward) and stroke (hazard ratio 1.22, 95% CI 1.10-1.35, P < 0.001). CONCLUSION: The results of this study suggest that OPCAB was associated with an increased risk of mortality, repeat myocardial revascularization and stroke at 10 years compared with on-pump CABG.

Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy in the Piedmont Region with an audit&feedback approach: Study protocol for a stepped wedge cluster randomized controlled trial. A study of the EASY-NET project.

INTRODUCTION: ERAS (Enhanced Recovery After Surgery) is a perioperative program combining multiple evidence-based interventions designed to reduce the surgical stress response. Despite the publication of dedicated guidelines, ERAS application to gynecologic surgery outside clinical studies has been slow and fragmented. To promote the systematic adoption of the ERAS program in the entire regional hospital network in Piedmont an Audit-and-Feedback approach (A&F) has been adopted within a cluster randomized controlled trial, aiming to estimate the true impact of the protocol on a large, unselected population. METHODS: The study protocol provides for a multicenter stepped wedge cluster randomized trial, focused on women undergoing an hysterectomy, for comparison between standard perioperative management and perioperative management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: post-operative complications, quality-of-recovery at 24-hours after surgery, 30-day readmissions, patients' satisfaction, healthcare costs. The compliance to all the ERAS items is monitored with an A&F approach. All the gynecologic units of Piedmont hospitals are involved and all the patients hospitalized for elective hysterectomy in the period of the study are included. Centers, stratified by surgical volume and randomly assigned to four groups, are randomly ordered to activate the ERAS protocol in four periods, every three months. The planned calendar and the total duration of the study have been extended for six months due to the COVID-19 pandemic. The expected sample size of about 2400 patients has a high statistical power (99%) to detect a reduction of LOS of 1 day (effect size 0.5) and to estimate clinically meaningful changes in the other study endpoints. The study protocol has been approved by the Ethical Committee of all participating centers. Study results will be timely circulated within the hospital network and published in peer-reviewed journals. CONCLUSION: Results are expected to demonstrate positive clinical outcomes of the ERAS protocol even when its implementation is directed towards an entire regional network of gynecologic units, and not only towards selected and highly motivated centers. TRIAL REGISTRATION: NCT04063072.

Health-related quality of life for normal glycaemia, prediabetes and type 2 diabetes mellitus: Cross-sectional analysis of the ADDITION-PRO study.

AIMS: We estimated and compared health-related quality of life for individuals with normal glucose tolerance, prediabetes and diabetes. METHODS: Participants in the ADDITION-PRO study, Denmark, who attended a health assessment between 2009 and 2011, and who completed the 3-level EuroQoL 5-dimensions (EQ-5D-3L) questionnaire were included. For the present study, they were classified as normal glucose tolerance, prediabetes and diabetes (screen-detected and known) using the 2019 American Diabetes Association criteria. Prediabetes was defined as impaired fasting glucose, impaired glucose tolerance or HbA1c between 5.7-6.4% (39-47 mmol/mol). EQ-5D-3L data were converted into utility scores using Danish and UK values, where '1' equals full health and '0' equals death. Regression models estimated the association between utility and the different glucose health states. RESULTS: The mean EQ-5D-3L score in the sample population was 0.86 ± 0.17 (median 0.85, interquartile range 0.76 to 1) using UK values. Almost half of the sample (48%) reported full health with an EQ-5D score of '1'. Individuals with known diabetes reported the lowest EQ-5D-3L utility scores (0.81 ± 0.20), followed by individuals with screen-detected diabetes (0.85 ± 0.19), prediabetes (0.86 ± 0.17) and normal glucose tolerance (0.90 ± 0.15). The differences were statistically significant for normal glucose and known diabetes relative to prediabetes, after adjusting for sex, age, smoking, BMI and physical activity. These findings also held using Danish values albeit the differences were of smaller magnitude. CONCLUSIONS: Having prediabetes and diabetes was significantly associated with lower health-related quality of life relative to normal glucose tolerance. Our estimates will be useful to inform the value of interventions to prevent diabetes or prediabetes.

Factor structure of post-operative quality of recovery questionnaire (QoR-15): An Italian adaptation and validation.

Background: The Quality of Recovery questionnaire (QoR-15) is an English instrument for measuring quality of recovery in surgical patients, not yet translated and validated in Italian when the Enhanced Recovery After Surgery (ERAS) Piemonte studies were planned. Objective: To produce the Italian version of the QoR-15 questionnaire, to evaluate its factorial structure and to assess the invariance between two types of surgery. Methods: The Italian version (QoR-15I) was obtained translating and adapting the original version to the Italian context. The validation was performed suppling the QoR-15I to 3,784 patients enrolled in two parallel stepped wedge cluster randomised trials (ERAS Colon-rectum Piemonte; ERAS Gyneco Piemonte). The factor structure and its invariance between types of surgery was tested using confirmatory bifactor model and multi-group analysis. Comparative fit index (CFI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR) fit indices and their changes between nested models were used to assess the factor structure and the invariance. Results: The bifactor model showed good fit (RMSEA = 0.049, CFI =0.957, SRMR = 0.036) and provided a general recovery factor and two specific factors for physical and mental recovery. Eighty-four percent of the common variance is attributable to the general factor, and thus the QoR-15I is sufficiently 'one-dimensional' with an adequate reliability (ωh = 0.70). The ωs values for the physical and mental recovery factors were 0.01 and 0.13, respectively. Multigroup analysis supported configural (RMSEA = 0.053, CFI = 0.950, SRMR = 0.035) and metric invariance (ΔRMSEA = -0.004; ΔCFI = -0.002; ΔSRMR = 0.014), whereas the intercept constraint was removed from item 15 to obtain partial scalar invariance (ΔRMSEA = 0.002; ΔCFI = 0.007; ΔSRMR = 0.004). Construct validity was supported by a negative association of QoR-15I scores with all variables related to worse patient condition and more complex surgery. Conclusion: Our results support the use of the QoR-15I as a valid, reliable, and clinically feasible tool for measuring the quality of recovery after surgery. The results of the confirmatory factor analyses suggest that a unique recovery score can be calculated and support measurement invariance of the QOR-15I across the two type of surgery, suggesting that the questionnaire has the same meaning and the same measurement parameters in colorectal and gynaecologic patients.

Effect of Bariatric Surgery on Survival and Hospitalizations in Patients with Severe Obesity. A Retrospective Cohort Study.

Bariatric surgery (BS) confers a survival benefit in specific subsets of patients with severe obesity; otherwise, effects on hospital admissions are still uncertain. We assessed the long-term effect on mortality and on hospitalization of BS in patients with severe obesity. This was a retrospective cohort study, including all patients residing in Piedmont (age 18-60 years, BMI ≥ 40 kg/m2) admitted during 2002-2018 to the Istituto Auxologico Italiano. Adjusted hazard ratios (HR) for BS were estimated for mortality and hospitalization, considering surgery as a time-varying variable. Out of 2285 patients, 331 (14.5%) underwent BS; 64.4% received sleeve gastrectomy (SG), 18.7% Roux-en-Y gastric bypass (RYGB), and 16.9% adjustable gastric banding (AGB). After 10-year follow-up, 10 (3%) and 233 (12%) patients from BS and non-BS groups died, respectively (HR = 0.52; 95% CI 0.27-0.98, by a multivariable Cox proportional-hazards regression model). In patients undergoing SG or RYGB, the hospitalization probability decreased significantly in the after-BS group (HR = 0.77; 0.68-0.88 and HR = 0.78; 0.63-0.98, respectively) compared to non-BS group. When comparing hospitalization risk in the BS group only, a marked reduction after surgery was found for all BS types. In conclusion, BS significantly reduced the risk of all-cause mortality and hospitalization after 10-year follow-up.

Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project.

INTRODUCTION: The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population. METHODS: A multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients' recovery, control of pain and patients' satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic.The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04037787.

Impact of gender on 10-year outcome after coronary artery bypass grafting.

OBJECTIVES: Our goal was to evaluate the impact of gender on the 10-year outcome of patients after isolated coronary artery bypass grafting (CABG) included in the Italian nationwide PRedictIng long-term Outcomes afteR Isolated coronary arTery bypass surgery (PRIORITY) study. METHODS: The PRIORITY project was designed to evaluate the long-term outcomes of patients who underwent CABG and were included in 2 prospective multicentre cohort studies. The primary end point of this analysis was major adverse cardiac and cerebrovascular events. Baseline differences between the study groups were balanced with propensity score matching and inverse probability of treatment. Time to events was analysed using Cox regression and competing risk analysis. RESULTS: The study population comprised 10 989 patients who underwent isolated CABG (women 19.6%). Propensity score matching produced 1898 well-balanced pairs. The hazard of major adverse cardiac and cerebrovascular event was higher in women compared to men [adjusted hazard ratio (HR) 1.13, 95% confidence interval (CI) 1.03-1.23; P = 0.009]. The incidence of major adverse cardiac and cerebrovascular event in women was significantly higher at 1 year (HR 1.31, 95% CI 1.11-1.55; P < 0.001) and after 1 year (HR 1.11, 95% CI 1.00-1.24; P = 0.05). Mortality at 10 years in the matched groups was comparable (HR 1.04, 95% CI 0.93-1.16; P = 0.531). Women have significantly a higher 10-year risk of myocardial infarction (adjusted HR 1.40, 95% CI 1.17-1.68; P = 0.002) and percutaneous coronary intervention (adjusted HR 1.32, 95% CI 1.10-1.59; P = 0.003). CONCLUSIONS: The present study documented an excess of non-fatal cardiac events after CABG among women despite comparable 10-year survival with men. These findings suggest that studies investigating measures of tertiary prevention are needed to decrease the risk of adverse cardiovascular events among women.

[The PRIORITY study - PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY]. / Lo studio PRIORITY - PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY.

The allocation of clinical and economic resources is an emerging issue in health management. A useful update necessarily depends on the evaluation of long-term outcomes of clinical and surgical resources that can permit emphasis on all amendable fields, improve quality of care, and reduce health costs. The PRIORITY (PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY) study represents the first innovative step toward the updating of health management in a selected field, surgery for coronary artery disease, which is one of the most prevalent diseases and requires allocation of high-cost resources, although information on long-term outcomes is limited. The aims of the PRIORITY study are the identification of preoperative risk factors for long-term outcomes and the development of clinical and administrative preoperative scores that can guide clinicians and the national health system to more appropriate actions for increasing quality of care and reducing costs.

Living with severe multiple sclerosis: Cost-effectiveness of a palliative care intervention and cost of illness study.

BACKGROUND: Little is known about the economic consequences of living with severe multiple sclerosis (SMS). AIMS: To assess the cost-effectiveness of a home-based palliative approach (HPA) for people with SMS (pwSMS). To assess direct healthcare costs in this population. METHODS: PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months. Direct healthcare costs were collected on a monthly basis. Incremental cost-effectiveness was gauged from a national healthcare system (NHS) and a personal perspective, considering the Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs), both completed at baseline, after three and six months. RESULTS: Of 78 randomized pwSMS, 76 (50 HPA, 26 usual care) were analyzed. Mean QALYs were close to zero, and the mean group difference was -0.006 (95% CI -0.057 to 0.044). The mean baseline-adjusted cost difference was € -394 (95% confidence interval, CI -3,532 to 2,743). POS-S-MS cost-effectiveness showed a slight mean reduction of symptom burden (-1.9; 95% CI -1.1 to 5.0) with unchanged costs. Mean direct costs due to MS were € 23,195/year, almost equally distributed between NHS (€ 13,108) and pwSMS (€ 10,087). Personal care, medications and home rehabilitation accounted for 80% of total expenditures. Most personal care costs were covered by pwSMS, and these costs were 3/4 of pwSMS out-of-pocket. CONCLUSIONS: The slight reduction of symptom burden produced by the HPA was not associated with an increase in costs. NHS and pwSMS almost equally sustained these costs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN73082124.

Perioperative Care in Colorectal Cancer Surgery before a Structured Implementation Program of the ERAS Protocol in a Regional Network. The Piemonte EASY-NET Project.

BACKGROUND: In 2019, the Enhanced Recovery After Surgery (ERAS) protocol for colorectal cancer surgery was adopted by a minority of hospitals in Piemonte (4.3 million inhabitants, north-west Italy). The present analysis aims to compare the level of application of the ERAS protocol between hospitals already adopting it (ERAS, N = 3) with the rest of the regional hospitals (non-ERAS, N = 28) and to identify possible obstacles to its application. METHODS: All patients surgically treated for a newly diagnosed colorectal cancer during September-November 2019, representing the baseline period of a randomized controlled trial with a cluster stepped-wedge design, were included. Indicators of compliance to the ERAS items were calculated overall and for groups of items (preoperative, intraoperative and postoperative) and analyzed with a multilevel linear model adjusting for patients' characteristics, considering centers as random effects. RESULTS: Overall, the average level of compliance to the ERAS protocol was 56% among non-ERAS centers (N = 364 patients) and 80% among ERAS ones (N = 79), with a difference of 24% (95% CI: -41.4; -7.3, p = 0.0053). For both groups of centers, the lowest level of compliance was recorded for postoperative items (42% and 66%). Sex, age, presence of comorbidities and American Society of Anesthesiologists (ASA) score were not associated with a different probability of compliance to the ERAS protocol. CONCLUSIONS: Several items of the ERAS protocol were poorly adopted in colorectal surgery units in the Piemonte region in the baseline period of the ERAS Colon-Rectum Piemonte study and in the ERAS group. No relevant obstacles to the ERAS protocol implementation were identified at patient level.

[Audit and Feedback approach in the CoViD-19 emergency: adaptation of the EASY-NET project in the AOU Città della Salute e della Scienza of Turin.] / Audit e Feedback nell'emergenza CoViD-19: adattamento del progetto EASY-NET nell'AOU Città della Salute e della Scienza di Torino.

CoViD-19 pandemic heavily impacted most on-going research activities, causing delays and need of re-programming. EASY-NET (NET-2016-02364191) is a network project, started in April 2019, co-funded by the Italian Ministry of Health and the participating regions. Within the general project, centred on the evaluation of Audit and Feedback (A&F) strategies in improving quality and equity in different health care contexts, the Piedmont region is responsible of the work package 3 (WP3) on specific oncology pathways and procedures. After a thorough evaluation of the impact of the CoViD-19 emergency on the WP3 activities, at the beginning of March 2020, the decision was to continue, with some adaptations, the audits already started, and to delay those in the early planning phase. The provisional availability of part of the time-persons involved in EASY-NET on one side, and the urgency of acquiring data on the management of the large number of CoViD-19 patients admitted to the study coordinator hospital on the other side, determined the personnel responsible of the WP3, in accordance with the hospital management, to invest these resources in monitoring the CoViD-19 hospitalized patients with both A&F activity and research objectives. Besides periodic reports, a web site, with restricted access to the involved health care personnel, was developed to allow a direct and timely consultation of graphics describing the flow of the patients, their management, and outcomes. This experience was made possible thanks to a favourable combination of different factors: the presence within the hospital of a group of experienced epidemiologists in A&F, the availability of extra resources, the strong support and collaboration by the hospital management and the readiness for authorisation by the Ethics Committee. We underline the need to provide a certain degree of flexibility in the long-term projects funded by the Ministry of Health, the extraordinary adaptability of the A&F approach also to emergency situations and the possibility of combining audit activities and research objectives in the same project.

[A&F to monitor and promote quality in healthcare during the COVID-19 emergency: the EASY-NET work]. / A&F per il monitoraggio e la promozione della qualità delle cure in emergenza COVID-19: il lavoro di EASY-NET.

We are presenting here the findings of the reaction to the COVID-19 epidemic during the period March to June 2020 of those centres participating in the research EASY-NET which is on-going in Italy, funded by the Ministry of Health and co-founded by the Regional Health Authorities. The objective of EASY-NET is to evaluate the effectiveness of the audit and feedback (A&F) strategies in different clinical and organizational settings in seven regions. As a negative consequence of the COVID-19 epidemic, the activities of the project have suddenly slowed down; nevertheless, the COVID-19 epidemic represented an opportunity to apply the A&F methodology and support the healthcare within the regional authorities in order to manage and monitor the impact of this new disease. The reaction to the crisis on behalf of EASY-NET was inconsistent across the participating regions for various reasons. Factors which influenced the reaction levels in relation to the rapidity and efficiency of the implementation of the A&F strategies were as follows: the varying epidemiological impact of the COVID-19 epidemic in the various territories, the different clinical and organizational context and availability of expert research teams together with A&F procedures which had already been tested before the start of the epidemic.

Tailoring chemotherapy supply according to patients' preferences: a quantitative method in colorectal cancer care.

Objectives: The aim of this study was to conduct a discrete choice experiment with patients affected by colorectal cancer to understand their preferences for different attributes of the chemotherapy supply. Our overall goal is to provide evidence on the relative importance of each attribute in order to tailor chemotherapy supply according to patients' priorities in the design or reorganization processes of cancer services.Methods: Focus groups were used to identify the attributes and levels for the discrete choice experiment. The attributes were: continuity of care, understanding, information, treatment choice, and time for therapy. Respondents were asked to choose between two mutually exclusive hypothetical alternatives of chemotherapy supply. Patients completed the discrete choice experiment along with the health-related quality of life and patients' satisfaction questions. Conditional and mixed logistic models were used to analyses the data.Results: Patients with colorectal cancer treated with chemotherapy (n = 76) completed the survey. The most important aspects of chemotherapy supply were: "Providing detailed and complete information" and "High ability in understanding" patients. Preferences were also influenced by the availability of a trusted doctor. Except for one attribute (waiting time for therapy), all other characteristics significantly influenced respondents' preferences.Conclusions: Results should support a policy of strengthening medical doctors' capabilities to communicate with patients, providing them complete information and involving them in the clinical decisions. Specifically, the findings should be used to improve the current provision of cancer care by identifying areas of preferred intervention from the perspectives of patients in order to tailor the service supply accordingly.

Use of Electronic Administrative Databases to Measure Quality Indicators of Breast Cancer Care: Experience of Five Regional Oncology Networks in Italy.

PURPOSE: Assuring quality of care, while maintaining sustainability, in complex conditions such as breast cancer (BC) is an important challenge for health systems. Here, we describe a methodology to define a set of quality indicators, assess their computability from administrative data, and apply them to a large cohort of BC cases. MATERIALS AND METHODS: Clinical professionals from the Italian Regional Oncology Networks identified 46 clinically relevant indicators of BC care; 22 were potentially computable using administrative data. Incident cases of BC diagnosed in 2016 in five Italian regions were identified using administrative databases from regional repositories. Each indicator was calculated through record linkage of anonymized individual data. RESULTS: A total of 15,342 incident BC cases were identified. Nine indicators were actually computable from administrative data (two structure and seven process indicators). Although most indicators were consistent with guidelines, for one indicator (blood tumor markers in the year after surgery, 44.2% to 64.5%; benchmark ≤ 20%), deviation was evident throughout the five regions, highlighting systematic overlooking of clinical recommendations. Two indicators (radiotherapy within 4 months after surgery if no adjuvant chemotherapy; 42% to 83.8%; benchmark ≥ 90%; and mammography 6 to 18 months after surgery, 55.1% to 72.6%; benchmark ≥ 90%) showed great regional variability and were lower than expected, possibly as result of an underestimation in indicator calculation by administrative data. CONCLUSION: Despite highlighting some limitations in the use of administrative data to measure health care performance, this study shows that evaluating the quality of BC care at a population level is possible and potentially useful for guiding quality improvement interventions.